Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Chicken, Goat Meat, Wild and Farm-Raised Fish and Shellfish, Perishable Agricultural Commodities, Peanuts, Pecans, Ginseng, and Macadamia Nuts, 2658-2707 [E9-600]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 74, Number 10 (Thursday, January 15, 2009)]
[Rules and Regulations]
[Pages 2658-2707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-600]



[[Page 2657]]

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Part II





Department of Agriculture





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Agricultural Marketing Service



7 CFR Parts 60 and 65



Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Chicken, Goat 
Meat, Wild and Farm-Raised Fish and Shellfish, Perishable Agricultural 
Commodities, Peanuts, Pecans, Ginseng, and Macadamia Nuts; Final Rule

Federal Register / Vol. 74, No. 10 / Thursday, January 15, 2009 / 
Rules and Regulations

[[Page 2658]]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Parts 60 and 65

[Docket No. AMS-LS-07-0081]
RIN 0581-AC26


Mandatory Country of Origin Labeling of Beef, Pork, Lamb, 
Chicken, Goat Meat, Wild and Farm-Raised Fish and Shellfish, Perishable 
Agricultural Commodities, Peanuts, Pecans, Ginseng, and Macadamia Nuts

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: The Farm Security and Rural Investment Act of 2002 (2002 Farm 
Bill), the 2002 Supplemental Appropriations Act (2002 Appropriations), 
and the Food, Conservation and Energy Act of 2008 (2008 Farm Bill) 
amended the Agricultural Marketing Act of 1946 (Act) to require 
retailers to notify their customers of the country of origin of covered 
commodities. Covered commodities include muscle cuts of beef (including 
veal), lamb, chicken, goat, and pork; ground beef, ground lamb, ground 
chicken, ground goat, and ground pork; wild and farm-raised fish and 
shellfish; perishable agricultural commodities; macadamia nuts; pecans; 
ginseng; and peanuts. The implementation of mandatory country of origin 
labeling (COOL) for all covered commodities, except wild and farm-
raised fish and shellfish, was delayed until September 30, 2008.
    The 2008 Farm Bill contained a number of provisions that amended 
the COOL provisions in the Act. These changes included the addition of 
chicken, goat, macadamia nuts, pecans, and ginseng as covered 
commodities, the addition of provisions for labeling products of 
multiple origins, as well as a number of other changes. However, the 
implementation date of September 30, 2008, was not changed by the 2008 
Farm Bill. Therefore, in order to meet the September 30, 2008, 
implementation date and to provide the newly affected industries the 
opportunity to provide comments prior to issuing a final rule, on 
August 1, 2008, the Department published an interim final rule with a 
request for comments for all of the covered commodities other than wild 
and farm-raised fish and shellfish. The Agency is issuing this final 
rule for all covered commodities. This final rule contains definitions, 
the requirements for consumer notification and product marking, and the 
recordkeeping responsibilities of both retailers and suppliers for 
covered commodities.

DATES: This final rule is effective March 16, 2009.

FOR FURTHER INFORMATION CONTACT: Erin Morris, Associate Deputy 
Administrator, Poultry Programs, AMS, USDA, by telephone on 202-720-
5131, or via e-mail at: erin.morris@usda.gov.

SUPPLEMENTARY INFORMATION: The information that follows has been 
divided into three sections. The first section provides background 
information about this final rule. The second section provides a 
discussion of the rule's requirements, including a summary of changes 
from the October 5, 2004, interim final rule for fish and shellfish and 
the August 1, 2008, interim final rule for the remaining covered 
commodities as well as a summary of the comments received in response 
to the relevant prior requests for comments associated with this 
rulemaking and the Agency's responses to these comments. The prior 
requests for comments include: The interim final rule for fish and 
shellfish published in the October 5, 2004, Federal Register (69 FR 
59708); the reopening of the comment period (for costs and benefits) 
for the interim final rule that was published in the November 27, 2006, 
Federal Register (71 FR 68431); the reopening of the comment period for 
all aspects of the interim final rule that was published in the June 
20, 2007, Federal Register (72 FR 33851); and the interim final rule 
for the remaining covered commodities that was published in the August 
1, 2008, Federal Register (73 FR 45106). The last section provides for 
the required impact analyses including the Regulatory Flexibility Act, 
the Paperwork Reduction Act, Civil Rights Analysis, and the relevant 
Executive Orders.

I. Background

Prior Documents in This Proceeding

    This final rule is issued pursuant to the 2002 Farm Bill, the 2002 
Appropriations, and the 2008 Farm Bill, which amended the Act to 
require retailers to notify their customers of the origin of covered 
commodities. In addition, the FY 2004 Consolidated Appropriations Act 
(Pub. L. 108-199) delayed the implementation of mandatory COOL for all 
covered commodities except wild and farm-raised fish and shellfish 
until September 30, 2006. The Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies Appropriations Act of 2006 
(Pub. L. 109-97) delayed the applicability of mandatory COOL for all 
covered commodities except wild and farm-raised fish and shellfish 
until September 30, 2008.
    On October 11, 2002, AMS published Guidelines for the Interim 
Voluntary Country of Origin Labeling of Beef, Lamb, Pork, Fish, 
Perishable Agricultural Commodities, and Peanuts (67 FR 63367) 
providing interested parties with 180 days to comment on the utility of 
the voluntary guidelines.
    On November 21, 2002, AMS published a notice requesting emergency 
approval of a new information collection (67 FR 70205) providing 
interested parties with a 60-day period to comment on AMS' burden 
estimates associated with the recordkeeping requirements as required by 
the Paperwork Reduction Act of 1995 (PRA). On January 22, 2003, AMS 
published a notice extending this comment period (68 FR 3006) an 
additional 30 days.
    On October 30, 2003, AMS published the proposed rule for the 
mandatory COOL program (68 FR 61944) with a 60-day comment period. On 
December 22, 2003, AMS published a notice extending the comment period 
(68 FR 71039) an additional 60 days. On June 20, 2007, AMS reopened the 
comment period for the proposed rule for all covered commodities (72 FR 
33917).
    On October 5, 2004, AMS published the interim final rule for fish 
and shellfish (69 FR 59708) with a 90-day comment period. On December 
28, 2004, AMS published a notice extending the comment period (69 FR 
77609) an additional 60 days. On November 27, 2006, the comment period 
was reopened on the costs and benefits aspects of the interim final 
rule (71 FR 68431). On June 20, 2007, the comment period was reopened 
for all aspects of the interim final rule (72 FR 33851).
    On August 1, 2008, AMS published an interim final rule for covered 
commodities other than fish and shellfish (73 FR 45106) with a 60-day 
comment period.

II. Summary of Changes From the Interim Final Rules

Definitions

    In the regulatory text for fish and shellfish (7 CFR part 60), a 
definition for ``commingled covered commodities'' has been added for 
clarity and to conform to the regulatory text for the other covered 
commodities.
    In the regulatory text for the remaining covered commodities (7 CFR 
part 65), the definition of ``ground beef'' has been modified in 
response to

[[Page 2659]]

comments. Under this final rule, the term ``ground beef'' has the 
meaning given that term in 9 CFR Sec.  319.15(a), i.e., chopped fresh 
and/or frozen beef with or without seasoning and without the addition 
of beef fat as such, and containing no more than 30 percent fat, and 
containing no added water, phosphates, binders, or extenders, and also 
includes products defined by the term ``hamburger'' in 9 CFR 319.15(b). 
A full explanation of this change is discussed in the Comments and 
Responses section.
    In 7 CFR part 65, the definition of ``lamb'' has been modified in 
response to comments to include mutton. Under this final rule, the term 
``lamb'' means meat produced from sheep.
    In 7 CFR part 65, the definition of ``NAIS-compliant system'' has 
been deleted in response to comments received as it is no longer 
needed.
    A definition of ``pre-labeled'' has been added to both 7 CFR part 
60 and 7 CFR part 65 for clarity in response to comments received. 
Under this final rule, the term ``pre-labeled'' means a covered 
commodity that has the commodity's country of origin, and, as 
applicable, method of production information, and the name and place of 
business of the manufacturer, packer, or distributor on the covered 
commodity itself, on the package in which it is sold to the consumer, 
or on the master shipping container. The place of business information 
must include at a minimum the city and state or other acceptable locale 
designation.
    In 7 CFR part 65, the definition of ``produced'' has been modified 
for clarity in response to comments. Under this final rule, the term 
``produced'' in the case of perishable agricultural commodities, 
peanuts, ginseng, pecans, and macadamia nuts means harvested.

Country of Origin Notification

Labeling Covered Commodities of United States Origin

    The August 1, 2008, interim final rule contained an express 
provision allowing U.S. origin covered commodities to be further 
processed or handled in a foreign country and retain their U.S. origin. 
The Agency received numerous comments requesting further clarification 
of this provision as well as comments requesting that it be deleted. 
Accordingly, under this final rule, this provision has been deleted. To 
the extent that it is allowed under existing Customs and Border 
Protection (CBP) and Food Safety and Inspection Service (FSIS) 
regulations, U.S. origin covered commodities may still be eligible to 
bear a U.S. origin declaration if they are processed in another country 
such that a substantial transformation (as determined by CBP) does not 
occur. In addition, to the extent that additional information about the 
production steps that occurred in the U.S. is permitted under existing 
Federal regulations (e.g., CBP, FSIS), nothing in this final rule 
precludes such information from being included. A full explanation of 
this change is discussed in the Comments and Responses section.

Country of Origin Notification for Muscle Cuts

    Under the August 1, 2008, interim final rule, if an animal was 
born, raised, and/or slaughtered in the United States and was not 
imported for immediate slaughter as defined in Sec.  65.180, the origin 
of the resulting meat products derived from that animal could have been 
designated as Product of the United States, Country X, and/or (as 
applicable) Country Y, where Country X and Country Y represent the 
actual or possible countries of foreign origin.
    During the comment period, the Agency received extensive feedback 
from livestock producers, members of Congress, and other interested 
parties expressing concern about the provision in the interim final 
rule that allowed U.S. origin product to be labeled with a mixed origin 
label. It was never the intent of the Agency for the majority of 
product eligible to bear a U.S. origin declaration to bear a multiple 
origin designation. The Agency made additional modifications for 
clarity.
    Under this final rule, for muscle cut covered commodities derived 
from animals that were born in Country X or (as applicable) Country Y, 
raised and slaughtered in the United States, and were not derived from 
animals imported for immediate slaughter as defined in Sec.  65.180, 
the origin may be designated as Product of the U.S., Country X, and (as 
applicable) Country Y.
    For muscle cut covered commodities derived from animals born, 
raised, and slaughtered in the U.S. that are commingled during a 
production day with muscle cut covered commodities derived from animals 
that were raised and slaughtered in the United States, and were not 
derived from animals imported for immediate slaughter as defined in 
Sec.  65.180, the origin may be designated, for example, as Product of 
the United States, Country X, and (as applicable) Country Y.
    For muscle cut covered commodities derived from animals that are 
born in Country X or Country Y, raised and slaughtered in the United 
States, that are commingled during a production day with muscle cut 
covered commodities that are derived from animals that are imported 
into the United States for immediate slaughter as defined in Sec.  
65.180, the origin may be designated as Product of the United States, 
Country X, and (as applicable) Country Y.
    In all of the cases above, the countries of origin may be listed in 
any order. In addition, if animals are raised in another country and 
the United States, provided the animals are not imported for immediate 
slaughter as defined in Sec.  65.180, the raising that occurs in the 
United States takes precedence over the minimal raising that occurred 
in the animal's country of birth.
    A full explanation of these changes is discussed in the Comments 
and Responses section.

Markings

    Under the October 5, 2004, interim final rule for fish and 
shellfish and the August 1, 2008, interim final rule for the remaining 
covered commodities, only those abbreviations approved for use under 
CBP rules, regulations, and policies were acceptable. The 2008 Farm 
Bill and the August 1, 2008, interim final rule expressly authorized 
the use of State, regional, or locality label designations in lieu of 
country of origin for perishable agricultural commodities, peanuts, 
pecans, ginseng, and macadamia nuts. In response to comments received, 
under this final rule, abbreviations may be used for state, regional, 
or locality label designations for these commodities whether 
domestically harvested or imported using official United States Postal 
Service abbreviations or other abbreviations approved by CBP. A full 
explanation of this change is discussed in the Comments and Responses 
section.

Recordkeeping

    The 2008 Farm Bill made changes to the recordkeeping provisions of 
the Act. Specifically, the 2008 Farm Bill states that records 
maintained in the course of the normal conduct of the business of such 
person, including animal health papers, import or customs documents, or 
producer affidavits, may serve as such verification. Under the 2008 
Farm Bill, the Secretary is prohibited from requiring the maintenance 
of additional records other than those maintained in the normal conduct 
of business. In addition to the changes made as a result of the 2008 
Farm Bill, other changes were made in the August 1, 2008, interim final 
rule to reduce the recordkeeping burden. Further changes are being made 
in this final rule in response to comments received.

[[Page 2660]]

    For retailers, this rule requires records and other documentary 
evidence relied upon at the point of sale by the retailer to establish 
a covered commodity's country(ies) of origin and method of production 
(wild and/or farm-raised), as applicable, to be either maintained at 
the retail facility or at another location for as long as the product 
is on hand and provided to any duly authorized representative of USDA, 
upon request, within 5 business days of the request. For pre-labeled 
products, the label itself is sufficient information on which the 
retailer may rely to establish the product's origin and method of 
production, as applicable, and no additional records documenting origin 
and method of production information are necessary. Under the August 1, 
2008, interim final rule, retailers were required to maintain these 
records for a period of 1 year.
    Under this final rule, upon request by USDA representatives, 
suppliers and retailers shall make available to USDA representatives, 
records maintained in the normal course of business that verify an 
origin and method of production (wild and/or farm-raised) claim, as 
applicable. Such records shall be provided within 5 business days of 
the request and may be kept in any location.
    Under this final rule, producer affidavits shall also be considered 
acceptable records that suppliers may utilize to initiate origin claims 
for all covered commodities, provided it is made by someone having 
first-hand knowledge of the origin of the covered commodity and 
identifies the covered commodity unique to the transaction.

Responsibilities of Retailers and Suppliers

    With regard to the ``safe harbor'' language that was contained in 
the October 30, 2003, proposed rule and the October 5, 2004, interim 
final rule, which allowed retailers and suppliers to rely on the 
information provided unless they could have been reasonably expected to 
have knowledge otherwise, based on comments received, similar ``safe 
harbor'' language has been included in this final rule. A complete 
discussion is contained in the Comments and Responses section of this 
final rule.
    With regard to the recordkeeping provision concerning livestock 
that are part of a NAIS-compliant system, in response to comments 
received, the Agency has clarified that packers who slaughter animals 
that are tagged with an 840 Animal Identification Number device without 
the presence of any additional accompanying marking indicating the 
origin as being a country other than the U.S. (i.e., ``CAN'' or ``M'') 
may use that information as a basis for a U.S. origin claim. In 
addition, packers that slaughter animals that are part of another 
country's recognized official system (e.g. Canadian official system, 
Mexico official system) may also rely on the presence of an official 
ear tag or other approved device on which to base their origin claims.
Highlights of This Final Rule
Covered Commodities
    As defined in the statute, the term ``covered commodity'' includes: 
Muscle cuts of beef, lamb, pork, chicken, and goat; ground beef, ground 
lamb, ground pork, ground chicken, and ground goat; wild and farm-
raised fish and shellfish; perishable agricultural commodities (fresh 
and frozen fruits and vegetables); peanuts; pecans; ginseng; and 
macadamia nuts.
Exemption for Food Service Establishments
    Under the statute and therefore this final rule, food service 
establishments are exempt from COOL labeling requirements. Food service 
establishments are restaurants, cafeterias, lunch rooms, food stands, 
saloons, taverns, bars, lounges, or other similar facilities operated 
as an enterprise engaged in the business of selling food to the public. 
Similar food service facilities include salad bars, delicatessens, meal 
preparation stations in which the retailer sets out ingredients for 
different meals and consumers assemble the ingredients into meals to 
take home, and other food enterprises located within retail 
establishments that provide ready-to-eat foods that are consumed either 
on or outside of the retailer's premises.
Exclusion for Ingredient in a Processed Food Item
    Items are excluded from labeling under this regulation when a 
covered commodity is an ingredient in a processed food item. Under this 
final rule, a ``processed food item'' is defined as: A retail item 
derived from a covered commodity that has undergone specific processing 
resulting in a change in the character of the covered commodity, or 
that has been combined with at least one other covered commodity or 
other substantive food component (e.g., chocolate, breading, tomato 
sauce), except that the addition of a component (such as water, salt, 
or sugar) that enhances or represents a further step in the preparation 
of the product for consumption, would not in itself result in a 
processed food item. Specific processing that results in a change in 
the character of the covered commodity includes cooking (e.g., frying, 
broiling, grilling, boiling, steaming, baking, roasting), curing (e.g., 
salt curing, sugar curing, drying), smoking (cold or hot), and 
restructuring (e.g., emulsifying and extruding).
    With regard to determining what is considered an ``other covered 
commodity'' with respect to fruits and vegetables, the Agency will 
generally rely on U.S. Grade Standards for fruits and vegetables to 
make the distinction of whether or not the retail item is a combination 
of ``other covered commodities''. For example, different colored sweet 
peppers combined in a package will require country of origin 
notification because there is one U.S. Grade Standard for sweet 
peppers, regardless of the color. As another example, there are 
separate U.S. Grade Standards for iceberg lettuce and romaine lettuce. 
Therefore, this type of salad mix will not be required to be labeled 
with country of origin information. While the Agency previously used 
this example in the preamble of the August 1, 2008, interim final rule 
and concluded that such a salad mix would be subject to COOL, the 
Agency now believes the use of U.S. Grade Standards in determining when 
a perishable retail item is considered a processed food item provides a 
bright line to the industry and is an easy and straightforward approach 
as regulated entities are already familiar with U.S. Grade Standards.
    There are limited exceptions to this policy. One exception occurs 
when there are different grade standards for the same commodity based 
on the region of production. For example, although there are separate 
grade standards for oranges from Florida, Texas, and California/
Arizona, combining oranges from these different regions would not be 
considered combining ``other covered commodities'' and therefore, a 
container with oranges from Texas and Florida is required to be labeled 
with country of origin information.
    As examples of processing steps that are considered to further 
prepare product for consumption, meat products that have been needle-
tenderized or chemically tenderized using papain or other similar 
additive are not considered processed food items. Likewise, meat 
products that have been injected with sodium phosphate or other similar 
solution are also not considered processed food items as the solution 
has not changed the character of the covered commodity. In contrast, 
meat products that have been marinated with a particular flavor such as 
lemon-

[[Page 2661]]

pepper, Cajun, etc. have been changed in character and thus are 
considered processed food items.
    While the definition of a processed food item does exclude a number 
of products from labeling under the COOL program, many imported items 
are still required to be marked with country of origin information 
under the Tariff Act of 1930 (19 U.S.C. 1304) (Tariff Act). For 
example, while a bag of frozen peas and carrots is considered a 
processed food item under this final rule, if the peas and carrots are 
of foreign origin, the Tariff Act requires that the country of origin 
information be marked on the bag. Likewise, while roasted peanuts, 
pecans, and macadamia nuts are also considered processed food items 
under this final rule, under the Tariff Act, if the nuts are of foreign 
origin, the country of origin information must be indicated to the 
ultimate purchaser. This also holds true for a variety of fish and 
shellfish items. For example, salmon imported from Chile that is smoked 
in the United States as well as shrimp imported from Thailand that is 
cooked in the United States are also required to be labeled with 
country of origin information under the Tariff Act. In addition, items 
such as marinated lamb loins that are imported in consumer-ready 
packages would also be required to be labeled with country of origin 
information as both CBP and FSIS regulations require meat that is 
imported in consumer-ready packages to be labeled with origin 
information on the package.
    Examples of items excluded from country of origin labeling include 
teriyaki flavored pork loin, meatloaf, roasted peanuts, breaded chicken 
tenders, breaded fish sticks, flank steak with portabella stuffing, 
steakhouse sirloin kabobs with vegetables, cooked and smoked meats, 
blue cheese angus burgers, cured hams, bacon, corned beef briskets, 
prosciutto rolled in mozzarella cheese, a salad that contains iceberg 
and romaine lettuce, a fruit cup that contains cantaloupe, watermelon, 
and honeydew, mixed vegetables, and a salad mix that contains lettuce 
and carrots and/or salad dressing.
Labeling Covered Commodities of United States Origin
    The law prescribes specific criteria that must be met for a covered 
commodity to bear a ``United States country of origin'' declaration. 
Therefore, covered commodities may be labeled as having a United States 
origin if the following specific requirements are met:
    (a) Beef, pork, lamb, chicken, and goat--covered commodities must 
be derived from animals exclusively born, raised, and slaughtered in 
the United States; from animals born and raised in Alaska or Hawaii and 
transported for a period of time not more than 60 days through Canada 
to the United States and slaughtered in the United States; or from 
animals present in the United States on or before July 15, 2008, and 
once present in the United States, remained continuously in the United 
States.
    (b) Perishable agricultural commodities, peanuts, pecans, ginseng, 
and macadamia nuts--covered commodities must be from products 
exclusively produced in the United States.
    (c) Farm-raised fish and shellfish--covered commodities must be 
derived exclusively from fish or shellfish hatched, raised, harvested, 
and processed in the United States, and that has not undergone a 
substantial transformation (as established by CBP) outside of the 
United States.
    (d) Wild fish and shellfish--covered commodities must be derived 
exclusively from fish or shellfish either harvested in the waters of 
the United States or by a U.S. flagged vessel and processed in the 
United States or aboard a U.S. flagged vessel, and that has not 
undergone a substantial transformation (as established by CBP) outside 
of the United States.
Labeling Country of Origin for Imported Products
    Under this final rule, a fish or shellfish imported covered 
commodity shall retain its origin as declared to CBP at the time the 
product enters the United States, through retail sale, provided it has 
not undergone a substantial transformation (as established by CBP) in 
the United States. Similarly, for the other covered commodities, an 
imported covered commodity for which origin has already been 
established as defined by the Act (e.g., born, raised, slaughtered or 
harvested) and for which no production steps have occurred in the 
United States shall retain its origin as declared to CBP at the time 
the product enters the United States, through retail sale.
    Covered commodities imported in consumer-ready packages are 
currently required to bear a country of origin declaration on each 
individual package under the Tariff Act. This final rule does not 
change these requirements.
Labeling Fish and Shellfish Imported Products That Have Been 
Substantially Transformed in the United States
    Under this final rule, in the case of wild fish and shellfish, if a 
covered commodity was imported from country X and substantially 
transformed (as established by CBP) in the United States or aboard a 
U.S. flagged vessel, the product shall be labeled at retail as ``From 
[country X], processed in the United States.'' Alternatively, the 
product may be labeled as ``Product of country X and the United 
States''. The covered commodity must also be labeled to indicate that 
it was derived from wild fish or shellfish.
    In the case of farm-raised fish, if a covered commodity was 
imported from country X at any stage of production and substantially 
transformed (as established by CBP) in the United States, the product 
shall be labeled at retail as ``From [country X], processed in the 
United States.'' Alternatively, the product may be labeled as ``Product 
of country X and the United States''. The covered commodity shall also 
be labeled to indicate that it was derived from farm-raised fish or 
shellfish.
Labeling Muscle Cut Covered Commodities of Multiple Countries of Origin 
(That Includes the United States)
    Under this final rule, for muscle cut covered commodities derived 
from animals that were born in Country X or (as applicable) Country Y, 
raised and slaughtered in the United States, and were not derived from 
animals imported for immediate slaughter as defined in Sec.  65.180, 
the origin may be designated, for example, as Product of the U.S., 
County X, and (as applicable) Country Y. The countries of origin may be 
listed in any order.
    For muscle cut covered commodities derived from animals born, 
raised, and slaughtered in the U.S. that are commingled during a 
production day with muscle cut covered commodities derived from animals 
that were raised and slaughtered in the United States, and were not 
derived from animals imported for immediate slaughter as defined in 
Sec.  65.180, the origin may be designated as, for example, Product of 
the United States, Country X, and (as applicable) Country Y. The 
countries of origin may be listed in any order.
    If an animal was imported into the United States for immediate 
slaughter as defined in Sec.  65.180, the origin of the resulting meat 
products derived from that animal shall be designated as Product of 
Country X and the United States.
    For muscle cut covered commodities derived from animals that are 
born in Country X or Country Y, raised and slaughtered in the United 
States, that are commingled during a production day with muscle cut 
covered commodities that are derived from animals that are imported 
into the

[[Page 2662]]

United States for immediate slaughter as defined in Sec.  65.180, the 
origin may be designated as Product of the United States, Country X, 
and (as applicable) Country Y. The countries of origin may be listed in 
any order.
    In all cases above, the origin declaration may include more 
specific information related to production steps provided records to 
substantiate the claims are maintained and the claim is consistent with 
other applicable Federal legal requirements. In addition, if animals 
are raised in another country and the United States, provided the 
animals are not imported for immediate slaughter as defined in Sec.  
65.180, the raising that occurs in the United States takes precedence 
over the minimal raising that occurred in the animal's country of 
birth.
    With regard to the commingling of meat of different origin 
categories, the Agency has received comments requesting that the Agency 
provide additional clarification on how commingled meat products can be 
labeled. Under this final rule, it is permissible to commingle meat 
derived from animals imported for immediate slaughter with meat derived 
from mixed origin animals and label it as Product of U.S., Canada. It 
is also permissible to commingle meat derived from animals imported for 
immediate slaughter with meat of mixed origin and label it as category 
C (product imported for immediate slaughter, i.e., Product of Canada, 
U.S.). Further, the declaration for meat derived from mixed origin 
animals may list the countries of origin in any order (e.g., Product of 
U.S., Canada or Product of Canada, U.S.).
Labeling Commingled Covered Commodities
    In this final rule, a commingled covered commodity is defined as a 
single type of covered commodity (e.g., frozen peas, shrimp), presented 
for retail sale in a consumer package, that has been prepared from raw 
material sources having different origins. Further, a commingled 
covered commodity does not include meat products. If the retail product 
contains two different types of covered commodities (e.g., peas and 
carrots), it is considered a processed food item and is not subject to 
mandatory COOL.
    In the case of perishable agricultural commodities, wild and farm-
raised fish and shellfish, peanuts, pecans, ginseng, and macadamia 
nuts, for imported covered commodities that have not subsequently been 
substantially transformed in the United States that are commingled with 
commodities having different origins, the declaration shall indicate 
the countries of origin for all covered commodities in accordance with 
CBP marking regulations (19 CFR part 134). For example, a bag of frozen 
peas that were sourced from France and India is currently required 
under CBP regulations to be marked with that origin information on the 
package.
    In the case of wild and farm-raised fish and shellfish covered 
commodities, when the retail product contains imported covered 
commodities that have subsequently undergone substantial transformation 
in the United States are commingled with other imported covered 
commodities that have subsequently undergone substantial transformation 
in the United States (either prior to or following substantial 
transformation in the United States) and/or U.S. origin covered 
commodities, the declaration shall indicate the countries of origin 
contained therein or that may be contained therein.
Defining Country of Origin for Ground Meat Products
    The law states that the origin declaration for ground beef, ground 
pork, ground lamb, ground goat, and ground chicken covered commodities 
shall list the countries of origin contained therein or shall list the 
reasonably possible countries of origin. Therefore, under this final 
rule, when a raw material from a specific origin is not in a 
processor's inventory for more than 60 days, the country shall no 
longer be included as a possible country of origin. This does not mean 
that labels must change every 60 days. Labels containing the applicable 
countries (e.g., Country x, y, z) may extend beyond a given 60-day 
period depending on how long raw materials from those countries are 
actually in inventory. If a country of origin is utilized as a raw 
material source in the production of ground beef, it must be listed on 
the label. The 60-day in inventory allowance speaks only to when 
countries may no longer be listed. The 60-day inventory allowance is an 
allowance for the Agency' enforcement purposes for when the Agency 
would deem ground meat products as no longer accurately labeled. In the 
event of a supplier audit by USDA, records kept in the normal course of 
business should provide the information necessary to verify the origin 
claim.
Remotely Purchased Products
    For sales of a covered commodity in which the customer purchases a 
covered commodity prior to having an opportunity to observe the final 
package (e.g., Internet sales, home delivery sales, etc.) the retailer 
may provide the country of origin and method of production information 
(wild and/or farm-raised), as applicable, either on the sales vehicle 
or at the time the product is delivered to the consumer.
Markings
    Under this final rule, the country of origin declaration and method 
of production (wild and/or farm-raised) designation, as applicable, may 
be provided to consumers by means of a label, placard, sign, stamp, 
band, twist tie, pin tag, or other clear and visible sign on the 
covered commodity or on the package, display, holding unit, or bin 
containing the commodity at the final point of sale to consumers. The 
country of origin declaration and method of production (wild and/or 
farm-raised) designation may be combined or made separately.
    With respect to the production designation, various forms of the 
production designation are acceptable, including ``wild caught,'' 
``wild,'' ``farm-raised,'' ``farmed,'' or a combination of these terms 
for products that contain both wild and farm-raised fish or shellfish 
provided it can be readily understood by the consumer and is in 
conformance with other Federal labeling laws. Designations such as 
``ocean caught,'' ``caught at sea'', ``line caught,'' ``cultivated,'' 
or ``cultured'' do not meet the requirements of this regulation. 
Alternatively, the method of production (wild and/or farm-raised) 
designation may also be in the form of a check box.
    In general, country abbreviations are not acceptable. Only those 
abbreviations approved for use under CBP rules, regulations, and 
policies, such as ``U.K.'' for ``The United Kingdom of Great Britain 
and Northern Ireland'', ``Luxemb'' for Luxembourg, and ``U.S.'' or 
``USA'' for the ``United States of America'' are acceptable. The Agency 
is aware of a few additional abbreviations allowed by CBP such as 
``Holland'' for The Netherlands and has posted this information on the 
COOL Web site.
    The declaration of the country of origin of a product may be in the 
form of a statement such as ``Product of USA,'' ``Produce of the USA'', 
or ``Harvested in Mexico''; may only contain the name of the country 
such as ``USA'' or ``Mexico''; or may be in the form of a check box 
provided it is in conformance with CBP marking regulations and other 
Federal labeling laws (i.e., FDA, FSIS). For example, CBP marking 
regulations (19 CFR part 134) specifically require the use of the words 
``product of'' in certain circumstances. The adjectival form of the 
name of a country may be used as proper

[[Page 2663]]

notification of the country of origin of imported commodities provided 
the adjectival form of the name does not appear with other words so as 
to refer to a kind or species of product. Symbols or flags alone may 
not be used to denote country of origin. The labeling requirements 
under this rule do not supersede any existing Federal legal 
requirements, unless otherwise specified, and any country of origin or 
method of production (wild and/or farm-raised) designation, as 
applicable, must not obscure or intervene with other labeling 
information required by existing regulatory requirements.
    For domestic and imported perishable agricultural commodities, 
macadamia nuts, peanuts, pecans, and ginseng, State, regional, or 
locality label designations are acceptable in lieu of country of origin 
labeling. Such designations must be nationally distinct. For example, 
Rio Grande Valley would not be an acceptable designation because 
consumer would not know whether the country of origin was the U.S. or 
Mexico. Abbreviations may be used for state, regional, or locality 
label designations for these commodities whether domestically harvested 
or imported using official United States Postal Service abbreviations 
or other abbreviations approved by CBP.
    With regard to the use of established State marketing programs such 
as ``California Grown'', ``Go TEXAN'', ``Jersey Fresh'', etc., these 
programs may be used for COOL notification purposes provided they meet 
the requirements to bear a U.S. origin declaration as specified in this 
final rule.
    In order to provide the industry with as much flexibility as 
possible, this rule does not contain specific requirements as to the 
exact placement or size of the country of origin or method of 
production (wild and/or farm-raised) declaration. However, such 
declarations must be legible and conspicuous, and allow consumers to 
find the country(ies) of origin and method of production, as 
applicable, easily and read them without strain when making their 
purchases, and provided that existing Federal labeling requirements 
must be followed. For example, the country of origin declaration may be 
located on the information panel of a package of frozen produce as 
consumers are familiar with such location for displaying nutritional 
and other required information. Likewise, in the case of store overwrap 
and other similar type products, which is the type of packaging used 
for fresh meat and poultry products, the information panel would also 
be an acceptable location for the origin declaration and method of 
production (wild and/or farm-raised) designation, as applicable, as 
this is a location that is currently utilized for providing other 
Federally-mandated labeling information (i.e., safe handling 
instructions, nutrition facts, and ingredients statement). However, to 
the extent practicable, the Agency encourages retailers and suppliers 
to place this information on the front of these types of packages, also 
known as the principal display panel, so it will be readily apparent to 
consumers.
    With respect to the use of signage for bulk displays for meat 
covered commodities, the Agency has observed that a vast majority of 
retailers are utilizing one sign for either the entire meat case or for 
an entire commodity type (i.e., chicken) to provide the country of 
origin notification. While the statute and this regulation provide 
flexibility in how country of origin information can be provided, the 
Agency believes that the use of such signage could potentially be false 
or misleading to consumers. For example, frequently display cases also 
contain noncovered meat commodities for which no origin information has 
been provided to the retailer. Thus a sign that states, ``all of our 
beef products are of U.S. origin'' may not be completely accurate and 
may be in violation of other Federal laws, regulations, and policies 
that have truth in labeling provisions such as the Federal Meat 
Inspection Act, the Federal Trade Commission's ``Made in the USA'' 
policies, and the Federal Food, Drug, and Cosmetic Act. The Agency 
encourages retailers to review signage that they have used in the 
implementation of the fish and shellfish program for alternative 
acceptable methods of providing COOL information.
    With regard to the provision in both the interim final rule for 
fish and shellfish and the interim final rule for the remaining covered 
commodities concerning bulk containers that allows the bulk container 
to contain a covered commodity from more than one country of origin, 
under this final rule, it remains permissible provided all possible 
origins are listed. For example, if a retailer puts apples from the 
U.S. and New Zealand in a bulk bin, the sign for the bin should list 
both the U.S. and New Zealand. If the retailer has apples in the store 
from New Zealand, but has not added these apples to the bulk bin, it 
would not be permissible to have New Zealand on the sign. Likewise in 
the case of fish, if a retailer has salmon from both the U.S. and Chile 
in the back of the store, but has only put out for display salmon from 
Chile, the country of origin designation should only list Chile. It 
would not be permissible to list both the U.S. and Chile at that time 
because it is not possible that the display contains salmon of U.S. 
origin.
Recordkeeping Requirements and Responsibilities
    The law states that the Secretary may conduct an audit of any 
person that prepares, stores, handles, or distributes a covered 
commodity for retail sale to verify compliance. As such, records 
maintained in the normal course of business that verify origin and 
method of production (wild and/or farm-raised) declarations, as 
applicable, are necessary in order to provide retailers with credible 
information on which to base origin and method of production 
declarations.
    Under this final rule, any person engaged in the business of 
supplying a covered commodity to a retailer, whether directly or 
indirectly (i.e., growers, distributors, handlers, packers, and 
processors, etc.), must make available information to the subsequent 
purchaser about the country(ies) of origin and method of production, as 
applicable, of the covered commodity. This information may be provided 
either on the product itself, on the master shipping container, or in a 
document that accompanies the product through retail sale provided it 
identifies the product and its country(ies) of origin and method of 
production, as applicable.
    Any person engaged in the business of supplying a covered commodity 
to a retailer, whether directly or indirectly, must maintain records to 
establish and identify the immediate previous source (if applicable) 
and immediate subsequent recipient of a covered commodity for a period 
of 1 year from the date of the transaction.
    In addition, the supplier of a covered commodity that is 
responsible for initiating a country of origin and, as applicable, 
method of production declaration, must possess records that are 
necessary to substantiate that claim for a period of 1 year from the 
date of the transaction. In an effort to reduce the recordkeeping 
burden associated with COOL, for that purpose, packers that slaughter 
animals that are tagged with an 840 Animal Identification Number device 
without the presence of any additional accompanying marking indicating 
the origin as being a country other than the U.S. (i.e., ``CAN'' or 
``M'') may use that information as a basis for a U.S. origin claim. In 
addition, packers that slaughter animals that are part of another 
country's recognized official system (e.g., Canadian official system,

[[Page 2664]]

Mexico official system) may also rely on the presence of an official 
ear tag or other approved device on which to base their origin claims. 
Producer affidavits shall also be considered acceptable records that 
suppliers may utilize to initiate origin claims, provided it is made by 
someone having first-hand knowledge of the origin of the covered 
commodity and identifies the covered commodity unique to the 
transaction.
    Under this final rule, any intermediary supplier handling a covered 
commodity that is found to be designated incorrectly as to the country 
of origin and/or method of production, as applicable, shall not be held 
liable for a violation of the Act by reason of the conduct of another 
if the intermediary supplier relied on the designation provided by the 
initiating supplier or other intermediary supplier, unless the 
intermediary supplier willfully disregarded information establishing 
that the country of origin and/or method of production, as applicable, 
was false.
    For an imported covered commodity, the importer of record as 
determined by CBP, must ensure that records: Provide clear product 
tracking from the United States port of entry to the immediate 
subsequent recipient and accurately reflect the country(ies) of origin 
of the item as identified in relevant CBP entry documents and 
information systems; and maintain such records for a period of 1 year 
from the date of the transaction.
    Under this final rule, retailers also have responsibilities. In 
providing the country of origin notification for a covered commodity, 
retailers are to convey the origin and, as applicable, method of 
production information provided by their suppliers. Only if the 
retailer physically commingles a covered commodity of different origins 
and/or methods of production, as applicable, in preparation for retail 
sale, whether in a consumer-ready package or in a bulk display (and not 
discretely packaged) (i.e., full service meat case), can the retailer 
initiate a multiple country of origin designation that reflects the 
actual countries of origin and methods of production, as applicable, 
for the resulting covered commodity.
    Records and other documentary evidence relied upon at the point of 
sale by the retailer to establish a covered commodity's country(ies) of 
origin and method of production, as applicable, must either be 
maintained at the retail facility or at another location for as long as 
the product is on hand and provided to any duly authorized 
representatives of USDA within 5 business days of the request. For pre-
labeled products, the label itself is sufficient information on which 
the retailer may rely to establish the product's origin and method of 
production, as applicable, and no additional records documenting origin 
and method of production information are necessary. A pre-labeled 
covered commodity is a covered commodity that has the commodity's 
country of origin and method of production, as applicable, and the name 
and place of business of the manufacturer, packer, or distributor on 
the covered commodity itself, on the package in which it is sold to the 
consumer, or on the master shipping container. The place of business 
information must include at a minimum the city and state or other 
acceptable locale designation.
    Additionally, records that identify the covered commodity, the 
retail supplier, and for products that are not pre-labeled, the country 
of origin and method of production information, as applicable, must be 
maintained for a period of 1 year from the date the origin declaration 
is made at retail.
    Under this final rule, any retailer handling a covered commodity 
that is found to be designated incorrectly as to the country of origin 
and/or method of production, as applicable, shall not be held liable 
for a violation of the Act by reason of the conduct of another if the 
retailer relied on the designation provided by the supplier, unless the 
retailer willfully disregarded information establishing that the 
declaration of country of origin and/or method of production, as 
applicable, was false.
Enforcement
    The law encourages the Secretary to enter into partnerships with 
States to the extent practicable to assist in the administration of 
this program. As such, USDA has entered into partnerships with States 
that have enforcement infrastructure to conduct retail compliance 
reviews.
    Routine compliance reviews may be conducted at retail 
establishments and associated administrative offices, and at supplier 
establishments subject to these regulations. USDA will coordinate the 
scheduling and determine the procedures for compliance reviews. Only 
USDA will be able to initiate enforcement actions against a person 
found to be in violation of the law. USDA may also conduct 
investigations of complaints made by any person alleging violations of 
these regulations when the Secretary determines that reasonable grounds 
for such investigation exist.
    Retailers and suppliers, upon being notified of the commencement of 
a compliance review, must make all records or other documentary 
evidence material to this review available to USDA representatives 
within 5 business days of receiving a request and provide any necessary 
facilities for such inspections.
    The law contains enforcement provisions for both retailers and 
suppliers that include civil penalties of up to $1,000 for each 
violation. For retailers and persons engaged in the business of 
supplying a covered commodity to a retailer (suppliers), the law states 
that if the Secretary determines that a retailer or supplier is in 
violation of the Act, the Secretary must notify the retailer or 
supplier of the determination and provide the retailer or supplier with 
a 30-day period during which the retailer or supplier may take 
necessary steps to comply. If upon completion of the 30-day period the 
Secretary determines the retailer or supplier has (1) not made a good 
faith effort to comply and (2) continues to willfully violate the Act, 
after providing notice and an opportunity for a hearing, the retailer 
or supplier may be fined not more than $1,000 for each violation.
    In addition to the enforcement provisions contained in the Act, 
statements regarding a product's origin and method of production, as 
applicable, must also comply with other existing Federal statutes. For 
example, the Federal Food, Drug, and Cosmetic Act prohibits labeling 
that is false or misleading. In addition, for perishable agricultural 
commodities, mislabeling country of origin is also in violation of PACA 
misbranding provisions. Thus, inaccurate country of origin labeling of 
covered commodities may lead to additional penalties under these 
statutes as well.
    With regard to the voluntary use of 840 tags on which to base 
origin claims, 9 CFR 71.22 prohibits the removal of official 
identification devices except at the time of slaughter. The importation 
of animals and animal health are regulated by the Animal and Plant 
Health Inspection Service (APHIS). This regulation does not alter any 
APHIS requirements.
Comments and Responses
    On October 30, 2003, AMS published the proposed rule for the 
mandatory COOL program (68 FR 61944) with a 60-day comment period. On 
December 22, 2003, AMS published a notice extending the comment period 
(68 FR 71039) an additional 60 days. AMS received over 5,600 timely 
comments from consumers, retailers, foreign governments, producers, 
wholesalers, manufacturers, distributors, members of

[[Page 2665]]

Congress, trade associations and other interested parties. The majority 
of the comments received were from consumers expressing support for the 
requirement to label the method of production of fish and shellfish as 
either wild and/or farm-raised. Numerous other comments related to the 
definition of a processed food item, the recordkeeping requirements for 
both retailers and suppliers, and the enforcement of the program. In 
addition, over 100 late comments were received that generally reflected 
the substance of the timely comments received.
    On June 20, 2007, AMS reopened the comment period for the proposed 
rule for all covered commodities (72 FR 33917). AMS received over 721 
comments from consumers, retailers, foreign governments, producers, 
wholesalers, manufacturers, distributors, members of Congress, trade 
associations and other interested parties.
    On October 5, 2004, AMS published the interim final rule for fish 
and shellfish (69 FR 59708) with a 90-day comment period. On December 
28, 2004, AMS published a notice extending the comment period (69 FR 
77609) an additional 60 days. AMS received approximately 800 comments 
on the interim final rule, the majority of which were form letters from 
consumers expressing their support for country of origin labeling and 
requesting that the definition of a processed food item be narrowed to 
require labeling of canned, breaded, and cooked products.
    On November 27, 2006, the comment period was reopened on the cost 
and benefit aspects of the interim final rule (71 FR 68431). AMS 
received over 192 comments from consumers, retailers, foreign 
governments, producers, wholesalers, manufacturers, distributors, 
members of Congress, trade associations and other interested parties. 
The majority of the comments received were from consumers expressing 
support for the requirement to label fish and shellfish with the 
country of origin and method of production as either wild and/or farm-
raised, and to extend mandatory COOL to the remaining covered 
commodities. Most of the comments did not address the specific question 
of the rule's costs and benefits. A limited number of the comments did 
relate to the costs and benefits of the documentation and recordkeeping 
requirements of the law. Some commenters noted no increased sales or 
demand for seafood as a result of COOL. Several commenters provided 
evidence regarding the costs of compliance with the interim final rule 
covering fish and shellfish. Other commenters cited academic and 
Government Accountability Office studies to argue that USDA 
overestimated the costs to implement systems to meet COOL requirements, 
and that the true costs to industry will be much lower than those 
projected by the economic impact analysis contained in the interim 
final rule for fish and shellfish. On August 1, 2008, AMS published an 
interim final rule with a 60-day comment period for the covered 
commodities other than fish and shellfish. The Agency received 275 
comments representing the opinions of 11,798 consumers, retailers, 
foreign governments, producers, wholesalers, manufacturers, 
distributors, members of Congress, trade associations and other 
interested parties. The majority of comments received were on the 
definition of a processed food item, labeling muscle cuts of multiple 
countries of origin, and the recordkeeping provisions for both 
retailers and suppliers.
    When the proposed rule was published on October 30, 2003, the 
regulatory provisions were all proposed to be contained in a new part 
60 of Title 7 of the Code of Federal Regulations. Under the August 1, 
2008, interim final rule, the regulatory provisions for the covered 
commodities other than fish and shellfish appeared at 7 CFR part 65. 
For the ease of the reader, the discussion of the comments has been 
broken down by issue. To the extent that a comment or issue pertains 
only to fish and shellfish covered commodities, it is noted in the 
explanation.

Definitions

Covered Commodity

    Summary of Comments: Several commenters requested that the Agency 
add products to the list of commodities covered by COOL. One commenter 
suggested that almonds should be included in mandatory COOL and another 
commenter requested that fresh chestnuts be added. A final commenter 
suggested that meat commodities derived from beefalo be included as 
covered commodities. Another commenter asked that the Agency better 
clarify what is a ``muscle cut.''
    Agency Response: The statute specifically defines the commodities 
covered by the mandatory COOL program. As such, the Agency does not 
have the authority to include additional classes of covered 
commodities. Accordingly, recommendations regarding covering additional 
classes of commodities cannot be adopted. With regard to clarifying 
what the Agency defined to be a muscle cut of beef, pork, lamb, 
chicken, or goat, the Agency has provided information on its Web site 
and in written form pertaining to specific items and will continue to 
do so as questions arise. In general, the Agency views those cuts of 
meat (with or without bone) derived from a carcass (e.g., beef steaks, 
pork chops, chicken breasts, etc.) to be covered items. However, cuts 
of meat that are removed during the conversion of an animal to a 
carcass (e.g., variety meats such as pork hearts, beef tongues, etc.) 
are not viewed to be muscle cuts nor are items sold as bones 
practically free of meat (e.g., lamb neck bones, beef femur bones, 
etc.) or fat practically free of meat (e.g., pork clear plate, chicken 
skin, etc.) removed from a carcass.

Ground Beef

    Summary of Comments: One commenter noted that fabricated steak is 
not specifically listed as a covered commodity in the law and expressed 
their belief that AMS could proactively cover a closely related 
commodity rather than limit COOL to only statutorily listed 
commodities. The commenter urged the Agency to broaden rather than 
narrow its scope of covered commodities to include fabricated steak in 
the definition of ground beef.
    Another commenter noted the rule exempts ground beef, hamburger and 
beef patties that have been seasoned (unless that seasoning is salt or 
sugar), but does not exempt ground beef, hamburger and beef patties 
that have not been seasoned. The commenter requested that the 
definition for ground beef be reconsidered and clarified so that ground 
beef, hamburger and beef patties where salt or sugar is added are 
recognized as a processed food item and therefore exempt under this 
rule.
    Several commenters did not agree that the Agency's expansion of the 
definition of ground beef to include hamburger and beef patties was 
justified. The commenters pointed out that the covered product 
specified by the 2008 Farm Bill is ``ground beef,'' which has its own 
regulatory standard of identity separate from hamburger and beef 
patties. One commenter also noted that the interim final rule's 
definitions of ``ground lamb'' and other ground meats do not similarly 
specify that patties made from such ground meats are covered items and 
suggested that this disparity appears to ``favor'' non-beef patties 
with possible exemption from the rule, to the disadvantage of beef 
patties. Another commenter stated that had Congress intended a more 
expansive range of processed food products to be subject to COOL, it 
would have specifically included them,

[[Page 2666]]

particularly where all other processed foods are categorically exempt 
from COOL requirements. The commenter urged the Agency to follow the 
intent of Congress and promulgate a rule that encompasses products 
captured in the regulatory standard of identity for ``ground beef'' and 
not extend the scope to items meeting other definitions.
    Agency Response: The Agency does not agree that commodities covered 
by the statute can be construed to cover fabricated steaks. Fabricated 
steaks are produced to appear like a whole muscle cut of meat but are 
in fact constructed from many different cuts of meat. Therefore, they 
are clearly not a ``muscle cut'' and, because the product is not ground 
nor is it sold as ground, it is not ground beef either.
    The Agency agrees that a regulatory standard of identity for the 
term ``ground beef'' exists, but does not agree that it was the intent 
of Congress to limit the mandatory COOL program to only those products 
marketed under that standard of identity. Further, the Agency believes 
it is not reasonable that consumers would understand why beef that is 
ground and marketed as ``ground beef'' would require labeling and beef 
that is ground and marketed as ``hamburger'' would not. The regulatory 
standard of identities for ``ground beef'' and ``hamburger'' are 
virtually identical with the minor exception of ``added fat'' being 
allowed in beef that is ground and marketed as ``hamburger''. Both are 
often marketed in bulk form or in patty form and can sit side by side 
in the fresh or frozen meat case with only the name capable of 
distinguishing them apart. Therefore, ground beef and hamburger sold in 
bulk or patty form are covered commodities under this final rule.
    However, in its analysis of the issue and the points raised by the 
commenters, the Agency does concur with several of the commenters that 
beef that is ground and marketed as ``imitation ground beef'', 
``imitation hamburger'', and ``beef patty mix'' should be exempt in 
this final rule. Products marketed under these standards of identities 
typically contain a number of binders and extenders that are not 
covered commodities and are not assumed by the consumer to be 
interchangeable with beef that is ground and marketed as ``ground 
beef'' or ``hamburger''. Because the Agency does not view such variety 
meat items as beef heart meat and tongue meat (which are not allowed in 
``ground beef'' or ``hamburger'') as covered commodities, requiring 
such products as ``beef patty mix'' to carry COOL information would 
also require the beef processing industry to identify the country of 
origin for such beef variety meat items in the event they would be used 
as extenders in commodities like ``beef patty mix'', which does allow 
their inclusion. The Agency believes that the costs associated with 
this segregation and identification of beef variety meats would be 
overly burdensome and that these items were not intended to be included 
as covered commodities under the statute. Accordingly, these 
recommendations are adopted in part.

Farm-Raised

    Summary of Comments: Some commenters expressed concerns regarding 
the definition of farm-raised in the fish and shellfish interim final 
rule. The commenters recommended that the Agency exempt molluscan 
shellfish from the COOL requirements.
    Agency Response: As the statute defines the term covered commodity 
to expressly include shellfish, the Agency does not have the authority 
to provide an exemption for molluscan shellfish. In addition, in the 
Agency's experience in three years of enforcement of the COOL program 
for fish and shellfish, it has found good compliance with the labeling 
of this commodity. Accordingly, this recommendation is not adopted in 
this final rule.

Lamb

    Summary of Comments: Several commenters requested that the 
regulation be revised to clarify the definition of lamb includes 
mutton. One of these commenters stated that because there are no common 
terminology differences describing the meat from different age groups 
of species such as cattle, swine, goat or chicken, the Agency was in 
error to exclude mutton in the definition of lamb in the interim final 
rule. The commenter further stated while specific definitional 
differences between lamb and mutton exist for other regulatory 
purposes, it is appropriate to cover meat from all ages of sheep in the 
rule as is done for the other livestock species.
    Agency Response: The Agency agrees that it is appropriate to 
include mutton under the definition of lamb as no distinctions 
describing meat from the different age groups of other livestock 
species were made. Accordingly, this recommendation has been adopted i